BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIBERTY CYCLER

    MDR report key: 2573834 · Received May 9, 2012

    Report

    Report Number
    2937457-2012-00018
    Event Type
    Other
    Date Received
    May 9, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM CODES. DEVICE CODE: (OTHER) UNKNOWN. REVIEW OF THE FLOW SHEETS REVEALS NO ABNORMALITY AND THE INITIAL MACHINE INVESTIGATION HAS FOUND NO EVIDENCE OF MALFUNCTION. UNABLE TO DETERMINE THE SOURCE OF THE 3100 ML MANUALLY DRAINED POST TREATMENT. DEVICE EVALUATED BY MANUFACTURER: (OTHER) INVESTIGATION IN PROGRESS. (B)(4).

    Description of Event or Problem · 1

    PATIENT CALLED TECH SUPPORT DUE TO EXPERIENCING DISCOMFORT OR PRESSURE IN HER ABDOMEN, CHEST PAINS, AND NAUSEA FOR A WEEK. THE NEXT DAY, PATIENT'S PD NURSE (B)(6) CALLED TECH SUPPORT REQUESTING A CYCLER REPLACEMENT FOR PATIENT'S COMPLAINT OF FEELING VERY FULL AND HAVING PAIN AND DISCOMFORT AFTER COMPLETING A CCPD TREATMENT. PATIENT THEN DID A MANUAL DRAIN AND OBTAINED 3,100 ML. FILL VOLUMES ARE 1,500 ML. PATIENT WAS OKAY AFTER DRAINING BUT WAS UNCOMFORTABLE USING THE CYCLER. TREATMENT DATA FROM THE CYCLER INDICATES THAT THE CYCLER HAD DRAINED APPROPRIATELY. PATIENT HAD DRAINED THE ENTIRE VOLUME FILL PLUS ADDITIONAL FLUID IN EACH CYCLE. REVIEW OF THE FLOW SHEETS REVEALS NO ABNORMALITY AND THE INITIAL MACHINE INVESTIGATION HAS FOUND NO EVIDENCE OF MALFUNCTION. NOTE: PATIENT HAD A HERNIA REPAIR APPROXIMATELY A YEAR AGO. THE HERNIA WAS BEING MONITORED AND EVALUATED BY A SURGEON WHO SCHEDULED A SURGERY DATE TO HAVE THE SAME HERNIA REPAIRED. THE SCHEDULING OF THE SURGERY PREDATED THE LARGE DRAIN EVENT. THE HERNIA REPAIR SURGERY OCCURRED AFTER THE LARGE DRAIN EVENT AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other LIBERTY CYCLER TUBING SET| PD SOLUTIONS